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Post by Deleted on Apr 21, 2015 15:00:55 GMT -5
In an interview last year, Al indicated they have the capability to load up to 36 units onto a cartridge. I would imagine large insurance companies are likely to negotiate a monthly rate as opposed to a per unit rate for this product. But this is super news in that T2's need much larger doses as they have an insulin resistance issue as opposed to t1's. This gets up to no more than 2 cartridges per meal up to 24 units. I would imagine the next size up will probably be 18 or 24/25 is probably the next size up. I have heard up to 50-100 units per meal for very insulin resistant T2's. On a very plus note. if 90% of your market is T2 vrs T1, then we get so much closer to a hard launch with advertising. Why bring in t2's if they are going to need to inhale 2-3 cartridges per dose.
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Post by benh on Apr 21, 2015 15:05:12 GMT -5
I am pretty certain that the manufacturing method (lines) had to be approved before the cartridge got the nod. I think 2 & 3 are running. I would have thought there was a milestone attached to the production capacity. Which should have released an 8K Filing.?
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Post by dstevenson on Apr 21, 2015 15:09:20 GMT -5
There was a milestone for getting inventory during last cc. I believe there are milestones for line 2 and 3. However do they need to announce right away when lines are certified?
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Post by liane on Apr 21, 2015 15:25:38 GMT -5
They have 4 business days to file 8K.
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Post by jpg on Apr 21, 2015 15:34:13 GMT -5
The more I look at it the more I think yesterdays 'take down' was a preemptive strike to good news... Without that people would have been excited. Now they are simply aware.
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Post by gomnkd on Apr 21, 2015 15:45:42 GMT -5
Instead of all these cartridges, they should come up with a new inhaler that has a reservoir, dial, mouth piece. The dial will have Units scale and upon setting, it'll move set amount from reservoir to staging area in mouthpiece. The inhalation will empty storage area's insulin. Patient can dial to any amount they need (0.5U to 20U) and inhale.
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Post by tripoley on Apr 21, 2015 15:59:11 GMT -5
Instead of all these cartridges, they should come up with a new inhaler that has a reservoir, dial, mouth piece. The dial will have Units scale and upon setting, it'll move set amount from reservoir to staging area in mouthpiece. The inhalation will empty storage area's insulin. Patient can dial to any amount they need (0.5U to 20U) and inhale. I've thought about this but the mechanics and other factors (like exposure to humidity) of it might be a bit difficult since you're working with a powder. A two unit cartridge would cover any dosage most adult patients would need using only two cartridges. The two unit cartridge might be useful in the T1. Amy Tenderich wanted to take six units I assume since she had a hypo on eight.
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Post by tigiron on Apr 21, 2015 16:00:56 GMT -5
Instead of all these cartridges, they should come up with a new inhaler that has a reservoir, dial, mouth piece. The dial will have Units scale and upon setting, it'll move set amount from reservoir to staging area in mouthpiece. The inhalation will empty storage area's insulin. Patient can dial to any amount they need (0.5U to 20U) and inhale. If this is technically feasible, don't you think they would have done this long time ago? Maybe use a manifold structure?
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Post by jpg on Apr 21, 2015 16:05:07 GMT -5
Instead of all these cartridges, they should come up with a new inhaler that has a reservoir, dial, mouth piece. The dial will have Units scale and upon setting, it'll move set amount from reservoir to staging area in mouthpiece. The inhalation will empty storage area's insulin. Patient can dial to any amount they need (0.5U to 20U) and inhale. Gomnkd? Is that you or did someone steal your alias? You are joking right? That is unrealistic (and I am holding back here big time). I am starting to question your thought process on some of these comments. For markets analysis you can get away with a lot because who knows how markets behave. Prices and valuation are short term unpredictable. For the science part of it you have to be careful so as not to overstep. I will consider this 'idea' a simple lapse in kinetics judgment from a non scientist financial analyst and nothing more (or someone stole your ID). If you want I am certain many of us who understand the science and needed logistics for what you are suggesting will explain how disconnected what you are suggesting sounds.
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Post by liane on Apr 21, 2015 16:12:58 GMT -5
Have to agree with jpg. I can think of dry powder inhalers, but they have a fixed dose. And I can think of variable dose liquid dispensers - such as the Flex-pen. But a variable dose dry powder dispenser - I can't think of any (of course I could be wrong). Also, TI is supposed to be kept refrigerated, so a large reservoir at room temp may not work.
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Post by notamnkdmillionaire on Apr 21, 2015 16:14:37 GMT -5
Instead of all these cartridges, they should come up with a new inhaler that has a reservoir, dial, mouth piece. The dial will have Units scale and upon setting, it'll move set amount from reservoir to staging area in mouthpiece. The inhalation will empty storage area's insulin. Patient can dial to any amount they need (0.5U to 20U) and inhale. I thought about that too but that then adds manufacturing complexity and cost. The brilliance of Afrezza is the very inexpensive dreamboat device that can be manipulated with just one hand. Doing what you want would really upset the one handed diabetics out there and we wouldn't want that, would we? Besides, I tend to think that a 2U isn't needed only because internally, MNKD has done the research and found there wouldn't be enough of a demand to justify the cost and that 4U is just the right minimal amount to cover what most diabetics need.
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Post by gomnkd on Apr 21, 2015 16:41:46 GMT -5
Instead of all these cartridges, they should come up with a new inhaler that has a reservoir, dial, mouth piece. The dial will have Units scale and upon setting, it'll move set amount from reservoir to staging area in mouthpiece. The inhalation will empty storage area's insulin. Patient can dial to any amount they need (0.5U to 20U) and inhale. Gomnkd? Is that you or did someone steal your alias? You are joking right? That is unrealistic (and I am holding back here big time). I am starting to question your thought process on some of these comments. For markets analysis you can get away with a lot because who knows how markets behave. Prices and valuation are short term unpredictable. For the science part of it you have to be careful so as not to overstep. I will consider this 'idea' a simple lapse in kinetics judgment from a non scientist financial analyst and nothing more (or someone stole your ID). If you want I am certain many of us who understand the science and needed logistics for what you are suggesting will explain how disconnected what you are suggesting sounds. Is this jpg or someone hijacked your id? I thought I am dealing with a professional and courteous person, not one who is condescending and rude. I don't know what is it with some people who are presented with an idea or thought that they cant agree with and just go nuts (my views on valuation, shorting etc). 1) I've a Masters in Engineering, I've background in electrical, electronics, little bit of applied mechanics, fluid mechanics, thermodynamics etc. That is 6 years of college (4 for Bachelors+2 yrs Masters). Do not assume someone's background just based on a few posts. I don't assume that you are just a pill pusher. 2) Have you seen/touched Afrezza inhaler? All it has is a little cartridge with powder and 5 cent plastic inhaler. This is not rocket science. I do understand it involves getting the powder of right shape, size, and getting flow right. 3) Do me a favor? Google Metered dose inhaler and read some material. Come back with some refutations. I am ignorant about medicine, but I learn all the time. I talk to lots of doctors and know how to do DD. This is my last post interacting with you.
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Post by BlueCat on Apr 21, 2015 16:44:50 GMT -5
My thoughts are the lines can handle multiple types. But inefficiencies grow as you switch between. Therefore, I imagine one line will be fully dedicated to 12u carts. Based on production math, the announcement of this line being up and running is going to be announced sooner rather than later. It has also occurred that having each line capable of producing the different sizes (but normally dedicated to 1 size) reduces the switching inefficiency and provides fault tolerance - However. It can also provide load balancing. Say for example, the 12u takes off like wildfire and they decide they want to build up that inventory fast. They could easily dedicate lines 2 and 3 to producing those, while letting line one continue to chug along switching back and forth between 4 and 8u. Yep. Totally geeking out here. But the potential of this is really cool.
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Post by BlueCat on Apr 21, 2015 16:50:32 GMT -5
Have to agree with jpg. I can think of dry powder inhalers, but they have a fixed dose. And I can think of variable dose liquid dispensers - such as the Flex-pen. But a variable dose dry powder dispenser - I can't think of any (of course I could be wrong). Also, TI is supposed to be kept refrigerated, so a large reservoir at room temp may not work. I had originally considered the idea of the dial-a-dose too, also ignorant to medical technology (and admittedly so) - as a patient, I've consumed both dial a dose liquid meds with pens, and also dry powder (Advair, etc). But beyond the logistics and also, the potential danger of OD(?), etc., I think Liane raises a very simple, salient reason this could be a bad idea: Refrigeration. Part of the beauty of TS and Afrezza is that the diabetics don't have to lug around a cooler. It'll keep for that plane ride, etc. I've had to lug a cooler for meds on and off over the years, and its a total (pun intended) drag. Especially going through airports, hot arid climates, etc. Can really appreciate that Afrezza can handle some normal temps for a while before requiring the fridge - but yea, dial a dose could possibly negate that. And if the number of doses were small enough to not matter for the cooling issue - would dial a dose actually be needed at that point? Just pack up a bag of cartridges ...
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Post by BlueCat on Apr 21, 2015 17:07:12 GMT -5
They have 4 business days to file 8K. Question - I thought they may be in some mandatory "quiet period" per SEC. So - which wins? Requirement to file 8k (but sans PR), or "quiet period?". Honestly don't know. And not 100% sure they are in quiet period. Just connecting social-chatter-dots.
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